Impact of the Early Start Denver Model on the Cognitive Level of Children with Autism Spectrum Disorder: First Results of the European French-Speaking Countries Study.

Background:

Early intervention for autism spectrum disorder (ASD) in the European French-speaking countries is heterogeneous and poorly evaluated to date. Early intervention units applying the Early Start Denver Model (ESDM) for toddlers and young children with ASD have been created in France and Belgium to improve this situation. It is essential to evaluate this intervention for the political decision-making process regarding ASD interventions in European French-speaking countries.

Objectives:

We will evaluate the effectiveness of 12 hours per week ESDM intervention on the cognitive level of children with ASD, over a 2-year period.

Methods:

The study is a multicenter, randomized controlled trial using a two-stage Zelen design. Children aged 15-36 months, diagnosed with ASD and with a developmental quotient (DQ) of 30 or above on the Mullen Scale of Early Learning (MSEL) are included. The sample size required is 180 children (120 in the control and 60 in the intervention group). The experimental group is scheduled to receive 12 hours of ESDM per week by trained therapists; 10 hours per week in the centre and 2 hours in the toddlers' natural environment (alternatively by the therapist and the parent). The control group is receiving care available in the community. The primary outcome will be the change in cognitive level measured with the DQ of the MSEL scored at 2 years. Secondary outcomes will include changes in autism symptoms, behavioral adaptation, communicative and productive language level, sensory profile and parents' quality of life. The primary analysis will use the intention-to-treat principle.

Results:

The first descriptive results of the cohort showed a very heterogeneous population on the MSEL DQ, nonverbal and verbal DQ, autism severity and behavioral adaptation. The protocol study is well accepted by the families, few data are missing and we have rare study discontinuation. We have very rare non-consent for children randomized in intervention group.

Conclusions:

This multicenter, randomized controlled trial is feasible and well accepted by the families. It will add information about the effectiveness of ESDM intervention in European French-speaking countries over a 2-year period. A follow-up study will also predict how this intervention reduces autism severity and the effects on schooling 5 years after the initial inclusion.